Caspofungin Based Combined Anti-fungal Therapy for Proven or Probable Invasive Fungal Infection

This study is currently recruiting participants.

Verified December 2011 by Shanghai Jiao Tong University School of Medicine

Sponsor:

Information provided by (Responsible Party):

Jiong HU, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT01501708

First received: December 26, 2011

Last updated: NA

Last verified: December 2011

History: No changes posted

Tracking Information

First Received Date ^ICMJE

December 26, 2011

Last Updated Date

December 26, 2011

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Favorable response rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Overall survival [ Time Frame: 12 weeks, 1 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Caspofungin Based Combined Anti-fungal Therapy for Proven or Probable Invasive Fungal Infection

Official Title ^ICMJE

Phase II Study of Caspofungin Based Combined Anti-fungal Therapy for Patients With Proven or Probable Invasive Fungal Infection After Allogeneic Stem Cell Transplantation From HLA-matched Unrelated or HLA-mismatched Related Donors

Brief Summary

In this prospective phase II observational study, we plan to assess the efficacy and tolerability of caspofungin based combined anti-fungal therapy for proven or probable IFI in a group of patients received allo-HSCT transplantation with high risk of IFI: HLA matched unrelated donor or mismatched donor conditioning with ATG containing regimen or present III-IV aGVHD or extensive GVHD undergoing high-dose steroid treatment.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Leukemia,
Allogeneic Hematopoietic Stem Cell Transplantation

Intervention ^ICMJE

Drug: Caspofugin + voriconazole or amphotericin B

Caspofungin: 70 mg on the ﬁrst day of therapy, followed by 50 mg q.d.

All patients received azoles as prophylaxis (fluconazole as prophylaxis and itraconazole or voriconazole as secondary prophylaxis), combination with liposomal amphotericin B at a dosage 3mg/kg q.d will be given.
In case of renal function damage, combination with voriconazole 6mg/kg followed by 4 mg/kg b.i.d. will be given.

Study Arm (s)

Experimental: Caspofugin

Intervention: Drug: Caspofugin + voriconazole or amphotericin B

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adult patient undergoing allogeneic hematopoietic stem cell transplantation
age 18-55 years
with inform consent
no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
HLA mismatched related (3~5/6) or unrelated donors (at least 8/10)
proven or probable IFI

Exclusion Criteria:

age less than 18 years or over 56 years
HLA mismatched related donor
liver function/renal function damage (over 2 X upper normal range)
with mental disease

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jiong HU, M.D.

86-21-64370045 ext 601818

hujiong@medmail.com.cn

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01501708

Other Study ID Numbers ^ICMJE

RJH-2011-71

Has Data Monitoring Committee

Responsible Party

Jiong HU, Shanghai Jiao Tong University School of Medicine

Study Sponsor ^ICMJE

Shanghai Jiao Tong University School of Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ling Wang, M.D.

Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Information Provided By

Shanghai Jiao Tong University School of Medicine

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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